Withdrawal of Prostacyclin Pathway Therapy in Patients With Pulmonary Arterial Hypertension Receiving Sotatercept (WATERLOO)

Sponsor
University of Alberta
Study ID
NCT07700303
Status
Not Yet Recruiting

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Conditions

  • Pulmonary Arterial Hypertension

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Discontinuation of parenteral prostacyclins analogues or selexipag — PROCEDURE
    Discontinuation of parenteral prostacyclins analogues or selexipag

Study Details

Pulmonary arterial hypertension (PAH) is a rare lung disease that leads to elevated blood pressure in the lungs and strain on the right side of the heart. For many years, treatments for PAH have included drugs that target the prostacyclin pathway using intravenous, subcutaneous, oral, and inhaled drugs. These drugs help widen the blood vessels in the lungs so the heart does not have to work as hard. However, these medicines can cause side effects such as jaw pain, flushing, diarrhea, and nausea, and the pump therapy can be very hard to manage day-to-day. A newer medicine called sotatercept works in a different way. It helps fix some of the root causes of PAH. Early reports suggest that some people do very well on sotatercept and may not need to keep taking their prostacyclin therapy. However, investigators do not yet know if it is safe to stop prostacyclin therapies or how to do so. This study, called WATERLOO, is designed to find out whether slowly stopping prostacyclin therapy while the participant is doing well on sotatercept is safe. Investigators will compare people who stop their prostacyclin therapy to people who keep taking it. This study is being done at PAH expert centres in Canada and Europe.

Key Dates

First listed
Jul 14, 2026
Start date
Sep 30, 2026
Status verified
Jul 2026
Primary completion
Mar 30, 2028
Completion
Mar 30, 2030

Study Design

Enrollment
78 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • No Intervention: Control group / no change to therapy
    The control group will continue prostacyclin pathway therapies as per their authorized indications, with no change in dosage.
  • Experimental: Prostacyclin pathway therapy withdrawal
    Dose de-escalation and discontinuation of parenteral prostacyclins analogues or selexipag

Primary Outcome Measure

Change in Mean Pulmonary Arterial Pressure (mPAP) From Baseline to 24 Weeks [ Time Frame: Baseline to 24 weeks ]

Central Contacts

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